Description
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Human Resource Development (DHRD) is announcing the availability of a cooperative agreement to be awarded under a Limited Competition. FDA can guarantee one year of funding with the possibility of up to four years of additional, noncompetitive support, dependent on performance and continued availability of federal funds.The national associations /organizations eligible to apply for funding under this cooperative agreement must be a national association/organization that represents State and local laboratories that conduct food and/or animal feed testing on behalf of State and local regulatory programs. Organizations as such are well positioned to represent FDA's laboratory counterparts in the IFSS, working together on regulatory, public health and food safety activities.The awardee will be required to sub award a minimum of 25% of the funds received under this award to at least two different associations in order to meet the goals of the cooperative agreement. One association must represent State manufactured food regulatory officials and the other association must represent State animal feed (food) regulatory officials. Prior approval of the sub awards by FDA is required. Training for federal, state and local food safety agencies is critically needed to fully develop an integrated food safety system (IFSS) for laboratories and human food and animal feed regulators and assist FDA in meeting the requirements of the Food Safety Modernization Act (FSMA) Section 209 (a)(a)(1-7) and the legal authority of Section 301 of the Public Health Service Act. . The Partnership for Food Protection (PFP) is the action arm of the IFSS. PFP has representative membership across the country from federal, state, and local regulators and advances the mission of the IFSS. The PFP has multiple workgroups with specific strategic plans and charges. The PFP’s Training and Certification Workgroup is charged to develop the National Curriculum Standard (NCS) for the more than 30,000 IFSS feed and food safety professionals operating in over 2,500 jurisdictions nationwide. The PFP Training and Certification Workgroup has spearheaded progress on the development of national curricula for IFSS food safety professionals, and to date is developing a national curriculum framework for the jobs conducted by laboratorians working with human and animal food.PART 1:The laboratory curriculum framework outlines the domain topic areas necessary for competency (outcome) based training (competency statements, key performance indicators, and field/lab bench application exercises need to be developed to reinforce training and enhance proficiency) spanning five professional levels: entry, mid-level, expert, supervisor/manager, and senior administration (agency specific training content is addressed by each jurisdiction). Following completion of the entry level general education requirements, trainees will continue in the entry level beginning their professional laboratory track and will be able to conduct independent activities while continuing their training and work at the mid-level.Laboratorians will be expected to continue their research into new and/or improved laboratory methods and training at the expert level and consider continuing through the supervisory/manager and senior administration levels as their desire, proficiency and opportunity enables them to do so.Awardee is expected to continue developing the IFSS Laboratory National Curriculum Standard research best practices on all five levels of the curriculum framework, beginning with the entry level and ascending as lower levels are completed utilizing the instructional design ideals espoused by FDA’s Office of Regulatory Affairs, Division of Human Resource Development (DHRD) and conduct research analysis for best methods of delivering training:Course Integrity: Training content is designed utilizing best practices in adult learning to meet course goals, objectives (terminal and enabling) and learning outcomes. Instructional systems specialists and instructional designers work with subject matter experts (SMEs) to align course content with effective and efficient training methods and modalities. Professional Staff: In the phases of analyzing, researching, designing, developing and evaluating training needs and content, there is an expectation that corresponding professional skill sets are utilized to conduct these activities such as instructional system specialists and designers, SMEs, program/project managers, industrial/organizational psychologists, and psychometricians.Analysis: Conducts research to identify the instructional objectives, training needs, learning environment, and learner's current knowledge and skill levels. Competencies addressing expectations for the newly acquired behavior, knowledge, and skill should be tied to the requirements for successful job performance. Needs Assessment, Job, task and/or competency analyses may be conducted to provide research to support a foundation and validation of IFSS employee development programs.Proficiency Levels: Establish course learning outcomes (cognitive, affective, and psychomotor) and learning standards consistent with accepted learning taxonomy (i.e. Bloom’s Taxonomy, Krathwohl's Taxonomy and Harrow's Taxonomy). Learning Outcomes: Developed consistent with industry accepted practices and standards such as Mager’s Theories on Criterion Referenced Instruction and the use of performance-based learning objectives. Learning outcomes define the competency expectations and provide the specificity of the desired behavior; what will personnel be able to do/demonstrate after completing a specific course and to what level of proficiency? Where practical, objectives are written using the performance, condition and criterion based methodology.Behaviors: The regulator’s mindset and conduct in carrying out regulatory activities need to be included as a component of the training content and process as behavioral science is an important component to job performance. Grantee should conduct research to ascertain and incorporate current behavioral science as it applies the various components of the laboratorian's job. Delivery Approach: Training that is primarily focused on knowledge and comprehension should occur outside of the classroom (i.e. online courses or independent reading assignments), while the application and/or demonstration components take place in a classroom setting. Thus in the classroom, “lecture” is minimized and interactive learning is emphasized. Training occurs over multiple learning events using a blended approach. Reinforcement should be provided to the degree necessary for reaching mastery of the job tasks.Evaluation: Conduct behavioral research to evaluate effective training and training effectiveness (i.e. Kirkpatrick Level 1 and 2, course assessments) of meeting course objectives. Legal Requirements: The design and development of training content needs to incorporate and adhere to 508 standards, FOI Act, Privacy Act, Plan Language, and Copyright (Title 17 and Fair Use) laws as applicable.Content Development: Course design documents, storyboards, web course templates utilizing Lectora 12 (software acquired by awardee(s)), and style guides: DHRD will provide the format/layout and design requirements for all training content being developed such as web courses, presentations, reading assignments, exercises, manuals (participant and/or instructor), course evaluations, training and/or job aids; all course materials are required to conform to the course development templates. Project Life Cycle: Content development is progressive and systematic, beginning with the design document that includes details such as project title and description, target audience, goals, objectives, learning outcomes, methods and modalities. To assure the design document is followed as the project is developed; periodic reviews are needed such as SME/ISD review of course content and instructional integrity. Where content lies within an online interface, their functionality, technical and instructional reviews will be necessary followed by pilot testing. Classroom courses require a “course walk through” for further refinements and a pilot (first class offering) in order to make any final content and/or delivery adjustments. Continue research and evaluations with delivery of future courses, both online and classroom to determine effectiveness and/or need for improvements. An overview of the NCS development status includes, but is not limited to:1. Adhere to FDA/DHRD’s NCS development and instructional design approach (above)2. Facilitate the lifecycle approach of competency and curriculum frameworks as developed/updated for the main framework and each program area3. Competency domain definitions address: a. Communication: Competencies related to communicating with diverse populations through verbal, written and non-verbal means b. Core: Competencies that cut across all domains c. Critical Thinking: Competencies related to objectively assessing information collected from a variety of sources by using a disciplined, analytical, and repeatable thought process while achieving a defensible conclusion d. Organizational Awareness: Competencies related to the understanding of the regulatory agency’s authority, structure, activities, and mission. e. Technical: Competencies related to the knowledge, skills, and abilities specifically relating to food and feed regulatory control4. Develop competency statements down to levels 5. This is a process that takes over arching competencies for a domain area down to sub-competency statements of increasing specificity for each topic or unit under a domain5. Validate competency statements to a minimum of level 46. Use DHRD’s templates for course design documents, story boards, web course templates, and/or style guides to develop course content based on research and analysis of data and findings with SMEs7. Review and pilot test course content 8. Established check points throughout the NCS development are required for approval prior to continuation of the projectThe application must include the following activities:1. Adhere to FDA's NCS development and instructional design approach (above)2. Develop annual work plans for continuing the development of the IFSS Laboratory NCS to include areas such as the level, domains, competency statements down to the appropriate level 5 to 7, and key performance indicators (KPI), in conjunction with FDA.3. Recruit IFSS laboratory subject matter experts (SME) to assist in the NCS development with FDA.4. Validate competency statements down to the level 4 (equivalent to the terminal learning objective for each unit within a course or domain topic area.5. Other activities as necessary to develop the IFSS Laboratory NCS.PART 2:Develop and/or Deliver Training Meeting the IFSS Laboratory National Curriculum Standard (NCS)The current model for delivering laboratory training to state and local regulatory agencies is not sufficient to meet the increased demand that now exists under FSMA and IFSS. Web and classroom courses and other learning events being developed and/or delivered must meet the NCS and in cooperation with FDA. To deliver FDA lab courses, tasks include related activities such as researching and conducting training need assessments for IFSS laboratories, train instructors (instructor skills training course), oversee/audit course instructors, course evaluations and updating courses based on feedback and FDA concurrence. These tasks may utilize subcontractors as needed. The resource goal for delivering FDA courses is cost efficiency for quality outputs while utilizing the most productive means. Course site selection should find that balance to minimize travel costs between course participants and the instructor cadre. Having the instructor cadre travel to the state or locality reduces travel costs for state/local regulators, whereas which town or city the course is hosted in can impact the instructors’ travel, lodging and per diem costs. Also, consideration should be given to the state or locality hosting a course if they can provide free government conference/training/lab space or a hotel may provide free or reduced conference room(s) costs with a room block.Funding is allocated to cover costs on mutually agreed upon projects within the scope of this cooperative agreement such as costs (direct and indirect) associated with course delivery, training instructors (“instructor skills training” and “course-specific instructor training” for each course i.e. LB101, LB102, etc.), instructor travel, lodging and per diem costs for course location, instructor salary or wages, course materials and supplies, shipping course materials/supplies, transportation for field trips, training need assessments, course certificates and records, and/or costs associated with course updates or development. Funding is not allocated for course participant travel, lodging, per diem, and salary or wages. Course participants are not to be charged a course entrance or registration fee. The application must include the following activities:1. Adhere to FDA's NCS development and instructional design approach (above)2. Recruit IFSS subject matter experts (SME) and provide instructor skills training (IST, general instructor skills that can be utilized in any course) to those SMEs identified as potential instructors. 3. For each instructor that has successfully completed the instructor skills training (IST), also needs to be trained on how to deliver each individual course or section(s) of a course whether an activity, exercise or lecture (course-specific instructor training). 4. Provide oversight of instructors to assure that they are delivering course content as instructed and not deviating from FDA’s intended delivery and utilizing their IST training skills as instructors.5. Make recommendations to FDA regarding course updates and new developments based on course feedback and training need research and assessments and may assist FDA in carrying out resulting projects with subcontractors as needed.6. Maintain training records for course participants, instructors and training need requests. Also issue course certificates for those successfully completing training and provide FDA with a copy of training records.7. Develop annual work plans for designing, developing blended learning courses/events in conjunction with FDA, to include monthly status reports to DHRD POC8. Develop annual work plans for training needs assessments and a course delivery schedule.FDA’s Role:FDA provides SMEs for FDA centric training content (FDA regulations and policy), project oversight, scientific input, content review and programmatic interaction with awardee(s) on activities within the scope of this cooperative agreement grant.